PITTSBURGH--Nearly three years after it began its investigation, the
federal Office of Research Integrity (ORI) has cleared Dr. Bernard Fisher
of any scientific misconduct, stating that he did not include false data
in his NSABP reports.

"Although I am pleased to get out a little bit from the cloud that
I was under, the real harm that was done is more pervasive," Dr. Fisher
said in an interview with Oncology News International. "Millions of
dollars of taxpayer's money were spent on this investigation that could
have been put into research."

As a result of the charges, ongoing NSABP trials were put on hold, including
the tamoxifen prevention study, "and women with breast cancer will
pay the price in the next few years," Dr. Fisher said. Perhaps most
important, he added, the publicity caused women needless worry about their
choice of lumpectomy plus radiation over mastectomy.

This "bizarre story of government and politics run amok,"
as Fisher describes it, began in 1991 when he notified the NCI of fraudulent
data from St. Luc Hospital in Montreal. In keeping with the "intent
to treat" principle, the patients from St. Luc were included in the
final analysis of the affected NSABP studies, including the landmark lumpectomy
study. "It must be emphasized that falsified data were not included
in any publications," Dr. Fisher said.

On March 13, 1994, an article in the Chicago Tribune appeared, accusing
Dr. Fisher of knowingly including false data in his reports; this spurred
Rep. John Dingell (D-Mich) to initiate a Congressional hearing on the issue.

Under pressure from Congress, the NCI ordered the ORI investigation,
and the University of Pittsburgh, in turn, removed Dr. Fisher from his
posts as director and principal investigator of the NSABP. (He is currently
Distinguished Service Professor in the Department of Surgery at the University
of Pittsburgh School of Medicine.)

Dr. Fisher has filed suit against the NIH, NCI, ORI, and the University
of Pittsburgh seeking full reinstatement and unspecified damages. The main
issue, he said, is the lack of due process in the investigation. "During
three years of investigations, no one from the ORI, NCI, or University
of Pittsburgh ever spoke to me or gave me a chance to speak."

The suit also alleges violations of Dr. Fisher's first amendment rights
in terms of academic freedom and freedom of speech. "I was being told
where to publish and what to publish, and my papers were subjected to prepublication
reviews," he said. "I am taking a stand so that this will not
happen to other scientists in the future."

Finally, the suit is about his desire to be back at his work with restored
responsibility and renewed vigor. "Women are still dying of breast
cancer, and as long as I have the ability to work, I want to continue to
do research in this field."

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